Using fluconazole to enhance treatment response in Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effects of fluconazole on the efficacy of IL-23 therapies in patients with Crohn's disease. Participants will be randomized into two groups: one receiving IL-23 therapy with fluconazole and the other receiving IL-23 therapy with a placebo. The study will assess patient responses through standard care visits and collect stool and blood samples at various intervals. The goal is to determine if fluconazole improves the response to IL-23 therapies when administered concurrently.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients at least 18 years old
2. Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450

Exclusion Criteria:

1. Antifungal usage within one month prior to initiation of blinded fluconazole usage
2. Known allergy to fluconazole
3. Patients with known hepatic disease, cirrhosis, or with elevated liver biochemistries (e.g., transaminase(s) \>3X upper limit of normal (ULN), and/or bilirubin levels \>1.5X ULN (with exception of confirmed Gilbert's disease) at baseline
4. Patients taking any medications judged by clinical provider to interact with fluconazole and are known contraindications (refer to section 2.2) and cause serious adverse events, including but not limited to death, cardiac events, serious cardiac dysrhythmias, and prolongation of QTc
5. Pregnant or lactating women
6. Severe Crohn's disease defined by a PRO-2 score ≥ 34 or imminent need for surgery, or deemed not medically fit by physician
7. Patient with symptomatic stricturing
8. Patient with pouchitis or an ostomy
9. Patients with known, active fungal infection(s) since these patients would require particular, standard-of-care monitoring and treatment, which may include intravenous and/or prolonged courses of fluconazole or other therapies.
10. Patients with hypokalemia, or advanced cardiac failure
11. Patients with renal insufficiency

Where it's running

• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Randy Longman, MD, PhD — Weill Medical College of Cornell University
• Study coordinator: Emely Fernandez, BS
• Email: emf4006@med.cornell.edu
• Phone: 646-697-0985

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.